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1、FDA发布咀嚼片关键质量属性指导原则（中英文对照）I.INTRODUCTIONI.引言ThisguidanceprovidesmanufacturersofchewabletabletsforhumanusewiththeCenterforDrugEvaluationandResearch's(CDER)currentthinkingonthecriticalqualityattributesthatshouldbeassessedduringthedevelopmentofthesedrugThisguidancealsopr
2、ovidesrecommendationsaboutsubmittingdevelopmental,manufacturing,andlabelinginformationforchewabletabletsthatmustbeapprovedbyCDERbeforetheycanbedistributed.Therecommendationsinthisguidanceapplymainlytonewdrugapplications(NDAs),abbreviatednewdrugapplications(ANDAs),3an
3、dcertainchemistry,manufacturing,andcontrols(CMC)supplementstothesesomeoftherecommendationsaboutthesubmissionofdevelopmentalinformationmayalsoapplytoinvestigationalnewdrugapplications(INDs).Therecommendationsaboutassessingcriticalqualityattributesapplytoallchewabletab
4、letsforhumanuse,includingnon-applicationproducts.本指南向生产者提供了药品审评研究中心(CDER对人用咀嚼片在研发过程中应评估的关键质量属性的当前想法2。该指南也提供了必须向CDEFW交并被其批准的咀嚼片的研发、生产及说明书信息的建议。该指南的这些建议主要针对新药申请(NDAs、仿制药申请(ANDAs3和一些化学、生产和质控(CMC补充申请4。某些建议同样适合于研究性新药申请(即新药临床申请，INDs)o关于评估关键质量属性的建议适用于所有人用咀嚼片，包括非申请产品。Ingener
5、al,FDA'sguidancedocumentsdonotestablishlegallyenforceableresponsibilities.Instead,guidancesdescribetheAgency'scurrentthinkingonatopicandshouldbeviewedonlyasrecommendations,unlessspecificregulatoryorstatutoryrequirementsarecited.TheuseofthewordshouldinAgencyguidancesm
6、eansthatsomethingissuggestedorrecommended,butnotrequired.通常,FDA的指导文件不具有法律强制性，指南中描述的主题仅代表FDAW构目前的看法，只作为建议，除非是引用具体的法规或条例要求。建议或推荐使用该指导原则，但不是必须的。II.BACKGROUND11II.目兄Chewabletabletsareanimmediaterelease(IR)oraldosageformintendedtobechewedandthenswallowedbythepatientrather
7、thanswallowedwhole.Theyshouldbedesignedtohaveapleasanttasteandbeeasilychewedandswallowed.Chewabletabletsshouldbesafeandeasytouseinadiversepatientpopulation,pediatric,adult,orelderlypatients,whoareunableorunwillingtoswallowintacttabletsduetothesizeofthetabletordifficu
8、ltywithswallowing.Theavailabilityofsafe,easy-to-usedosageformsisimportantinclinicalpractice.Chewabletabletsareavailableformanyover-
